Compositions and methods for treating inflammatory bowel disease using CCR9 inhibitor and anti-TNF-alpha blocking antibodies

Abstract

Provided herein are compositions, methods and kits for treating inflammatory bowel disease (IBD) such as Crohn's disease and ulcerative colitis in a mammal in need thereof. The method include administering to a subject with IBD a combination therapy containing a therapeutically effective amount of a chemokine receptor 9 (CCR9) inhibitor compound and a therapeutically effective amount of an anti-TNFα antibody. Also provided herein is a kit containing the CCR9 inhibitor compound and anti-TNFα antibody.

What is claimed is: 
     
       1. A method of treating or reducing the development of inflammatory bowel disease in a mammal, said method comprising administering a suitable amount of a CCR9 inhibitor with an anti-TNFα blocking antibody, wherein the CCR9 inhibitor is Compound 1 
       
         
           
           
               
               
           
         
       
     
     
       2. The method of  claim 1 , wherein the inflammatory bowel disease is Crohn's disease (CD) or ulcerative colitis (UC). 
     
     
       3. The method of  claim 1 , wherein the anti-TNFα blocking antibody is infliximab, adalimumab, golimumab, certolizumab pegol, or a biosimilar, biobetter, or bioequivalent thereof. 
     
     
       4. The method of  claim 1 , wherein the CCR9 inhibitor and the anti-TNFα blocking antibody are administered in a combination formulation. 
     
     
       5. The method of  claim 1 , wherein the CCR9 inhibitor and the anti-TNFα blocking antibody are administered sequentially. 
     
     
       6. The method of  claim 5 , wherein the CCR9 inhibitor is administered prior to the anti-TNFα blocking antibody. 
     
     
       7. The method of  claim 5 , wherein the CCR9 inhibitor is administered after administration of the anti-TNFα blocking antibody. 
     
     
       8. The method of  claim 1 , wherein the anti-TNFα blocking antibody is infliximab, or a biosimilar, biobetter, or bioequivalent thereof. 
     
     
       9. The method of  claim 1 , wherein the anti-TNFα blocking antibody is adalimumab, or a biosimilar, biobetter, or bioequivalent thereof. 
     
     
       10. The method of  claim 1 , wherein the anti-TNFα blocking antibody is golimumab, or a biosimilar, biobetter, or bioequivalent thereof. 
     
     
       11. The method of  claim 1 , wherein the anti-TNFα blocking antibody is certolizumab pegol, or a biosimilar, biobetter, or bioequivalent thereof. 
     
     
       12. A composition for treating or reducing the development of inflammatory bowel disease in a mammal, said composition comprising a therapeutically effective amount of a CCR9 inhibitor, a therapeutically effective amount of an anti-TNFα blocking antibody, and a pharmaceutically acceptable carrier or excipient, wherein the CCR9 inhibitor is Compound 1 
       
         
           
           
               
               
           
         
       
     
     
       13. The composition of  claim 12 , wherein the anti-TNFα blocking antibody is infliximab, adalimumab, golimumab, or a biosimilar, biobetter, or bioequivalent thereof. 
     
     
       14. A kit for treating or reducing the development of inflammatory bowel disease in a mammal, said kit comprising a therapeutically effective amount of a CCR9 inhibitor, and a therapeutically effective amount of an anti-TNFα blocking antibody, with instructions for effective administration, wherein the CCR9 inhibitor is Compound 1 
       
         
           
           
               
               
           
         
       
     
     
       15. The kit of  claim 14 , wherein the CCR9 inhibitor and the anti-TNFα blocking antibody are formulated for sequential administration. 
     
     
       16. The kit of  claim 14 , wherein the CCR9 inhibitor and the anti-TNFα blocking antibody are formulated for concomitant administration.